Regeneration of Human Intrabony Defects With rhFGF-2/HA

NCT02337166 | Completed Phase 1 DMC

• 1 other identifier: CEP-HUAM/CCM 21/03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND: Periodontal disease is an infection that results in progressive loss of dental support, which may lead to tooth loss.. The goal of the present study was to evaluate if recombinant human Fibroblast Growth Factor type 2 (rhFGF-2) applied in periodontal intrabony defects in a hyaluronic acid (HA) carrier would enhance the clinical paramenters of regeneration of the periodontal attachment apparatus and the long-term maintenance of the results obtained. METHODS: Thirty adult patients were evaluated. Initial treatment consisted in plaque control measures executed previously to the experimental phase. Two intra-bony defects in each patient were ramdomly allocated for each of the treatment methods employed. Control group (n=30) were treated by open debridement with the papilla preservation flaps, while the text group (n=30) also received a topical application of rhFGF-2/HA in the intrabony defect. The parameters evaluated were, probing depth (PD), gingival recession (REC), probing attachment level (PAL) and probing bone level (PBL). Clinical measurements obtained at baseline and 1, 5 and 10 years after the surgical procedure were compared.

Conditions

Periodontitis

Keywords

alveolar bone loss; periodontal attachment loss

Outcome Measures

Primary Outcomes (2)

• Probing attachment level gain

  up to 10 years

• Bone level gain

  up to 10 years

Study Arms (2)

Control

ACTIVE COMPARATOR

open instrumentation of the root surfaces and bone defects via flap modified papilla preservation flap

Procedure: Periodontal flap surgery

Test

EXPERIMENTAL

open instrumentation of the root surfaces and bone defects via flap modified papilla preservation flap and application of a rhFGF-2/HA in the intrabony defect

Device: a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate

Interventions

a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate DEVICE

0.2ml of a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate MW 1.3 x 106

Test

Periodontal flap surgery PROCEDURE

Control

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) adult subjects with chronic periodontitis presenting (b) radiographic evidence alveolar bone loss at the proximal aspect of the tooth, (c) intrabony defect deeper than 4mm, (d) probing pocket depth \>6 mm at the site, (e) unremarkable general health according to medical history and clinical judgment, (f) no medications taken for at least six months and no antibiotics taken for twelve months before the beginning of the study.

You may not qualify if:

• (a) subjects with "early onset" or aggressive forms of periodontitis, (b) current smokers, (c) presence of significant systemic diseases (i.e., cancer, AIDS, diabetes), (d) clinical evidence of furcation defects, (e) presence of apical radioleucency and (f) previous lack of cooperation with the maintenance program.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

MeSH Terms

Conditions

Periodontitis; Alveolar Bone Loss; Periodontal Attachment Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Ronaldo B Santana, DDS,MScD,DSc

  Federal Fluminense University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: December 1, 2002
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 13, 2015

Record last verified: 2015-01